Randomised Evaluation of COVID-19 Therapy (RECOVERY)

Research summary

Background: In early 2020, as this protocol was being developed, there were no approved treatments for COVID-19, a disease induced by the novel coronavirus SARS-CoV-2 that emerged in China in late 2019. A range of potential treatments have been suggested for COVID-19 but nobody knows if any of them will turn out to be more effective in helping people recover than the usual standard of hospital care which all patients will receive. The RECOVERY Trial will begin by testing some of these suggested treatments: MAIN RANDOMISATION A: - No additional treatment (standard of care). - Lopinavir-Ritonavir (commonly used to treat HIV) - NOW CLOSED DUE TO PRELIMINARY RESULTS SHOWING NO ADDITIONAL EFFICACY. - Low-dose Dexamethasone (a type of steroid, which is used in a range of conditions typically to reduce inflammation). OPEN TO CHILDREN ONLY AS OF 08/06/2020. - Hydroxychloroquine (related to an anti-malarial drug) - NOW CLOSED DUE TO PRELIMINARY RESULTS SHOWING NO ADDITIONAL EFFICACY. - Azithromycin (a commonly used antibiotic) - NOW CLOSED AS SUFFICIENT PATIENTS RECRUITED. - Colchicine (an anti-inflammatory drug). - NOW CLOSED DUE TO LACK OF EFFICACY. - Dimethyl fumarate (Tecfidera) (an immune modulator) - early phase assessment, only open at a sub-set of sites. - CLOSED TO RECRUITMENT AS OF 17/11/2021. MAIN RANDOMISATION B: - No additional treatment (standard of care). - ABO-compatible convalescent plasma (provided by NHS BT) - CLOSED TO RECRUITMENT DUE TO FUTILITY. - Synthetic neutralising antibodies: developed to bind to and neutralise the virus. - CLOSED TO RECRUITMENT. MAIN RANDOMISATION C: - No additional treatment (standard of care). - Aspirin (150mg) - CLOSED DUE TO SUFFICIENT RECRUITMENT 21/03/2021. SECOND RANDOMISATION: - No additional treatment (standard of care). - Tocilizumab (an anti-inflammatory treatment given by injection) - CLOSED TO RECRUITMENT AS OF 25/01/21. - Baricitinib (an anti-inflammatory treatment given by injection) - CLOSED TO RECRUITMENT AS OF LATE DEC 2021. - Empagliflozin (film-coated tablet). For paediatric patients presenting with the PIMS-TS phenotype, randomisation will be between: - Standard of care. - Normal human immunoglobulin (IVIg) - single dose has been shown to be effective in immunomodulation and preventing cardiovascular complications in Kawasaki disease, an inflammatory condition with overlapping clinical features with PIMS-TS. - Methylprednisolone sodium succinate (a type of steroid). - Tocilizumab (an anti-inflammatory treatment given by injection). - CLOSED TO CHILDREN AS OF 11pm 18th FEBRUARY 2022. - Anakinra (and anti-inflammatory treatment given by injection). - CLOSED TO CHILDREN AS OF 11pm 18th FEBRUARY 2022. MAIN RANDOMISATION G: - No additional treatment (standard of care). - Baloxavir marboxil. MAIN RANDOMISATION H: - No additional treatment (standard of care). - Oseltamivir. MAIN RANDOMISATION I: - No additional treatment (standard of care). - Low-dose corticosteroids: Dexamethasone. Specific medication modifications for pregnant women and paediatric patients can be found in the protocol (https://www.recoverytrial.net/for-site-staff/site-set-up-1/regulatory-documents) Data from the trial will be regularly reviewed so that any effective treatment can be identified quickly and made available to all patients. The RECOVERY Trial team will constantly review information on new drugs and include promising ones in the trial. Outcomes: The main outcomes will be in-hospital death, discharge, and need for ventilation. For the main analyses, follow-up will be censored at 28 days after admission. Additional information on longer term outcomes may be collected through review of medical records or linkage to medical databases such as those managed by NHS Digital and equivalent organisations in the devolved nations. Arms currently open in the UK as of January 2022: High dose dexamethasone. Empagliflozin comparison. Sotrovimab comparison. Future arms: Molnupiravir. Paxlovid.

Principal Investigator

Dr Brian Angus

Contact us

Email: sally.beer@ouh.nhs.uk

IRAS number

281712